What we are studying
This is a clinical trial for patients with brain metastasis as a result of non-small cell lung cancer. Brain metastases occur when cancer cells from your lung cancer spread to the brain resulting in tumor(s) in the brain. This is the most common type of cancer in the brain. A metastatic brain tumor is usually found when a cancer patient begins to experience neurological symptoms and a brain scan (CT or MRI) is ordered. However, some subjects are symptom-free and are only diagnosed with brain metastases
with MRI or CT scans for another reason.
The purpose of this study is to obtain information on the safety and effectiveness of NovoTTF-100M (study device) in subjects with brain metastases (tumors) as a result of non-small cell lung cancer. NovoTTF-100M is an experimental device and there may be no direct benefit to you from participating in this study. Approximately 270 patients will take part in this research in the U.S., Canada, Europe, Korea, and Japan.
Stereotactic radiosurgery (SRS) is commonly used as a treatment for brain metastases (tumors) and is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to a small spot in the brain (your tumor) while excluding the surrounding normal brain.
The NovoTTF-100M system is an investigational medical device for patients with diagnosis of non-small cell lung cancer, above 18 years of age, with 1-10 brain metastases. The NovoTTF-100M system is a portable, battery operated device which delivers Tumor Treating Fields (TTFields) to the tumor noninvasively, by means of insulated transducer arrays. The TTFields therapy produces electric forces intended to disrupt cancer cell division. The NovoTTF-100L is name of the device when used to treat lung cancer in the lungs.
Participants will be randomly assigned to one of two groups - supportive care or the NovoTTF-100M group. If you are assigned to the supportive care alone group you will receive radiosurgery first followed by supportive care available at the facility where you are being treated. Supportive care focuses on controlling the symptoms of your brain tumors, such as swelling of the brain and/or seizures. You will not receive the NovoTTF-100M. If you are assigned to the NovoTTF-100M group, you will receive radiosurgery first and then begin using NovoTTF-100M along with supportive care available at the facility where you are being treated. Supportive care focuses on controlling the symptoms of your brain tumors, such as swelling of the brain and/or seizures.
Novocure will reimburse for some travel expenses (not to exceed $500/month) for your travel to and from the study site for study related visits and to the Novocure technical center (if applicable). Patients may also be reimbursed up to $200 towards the